Blood collection and sampling apparatus having separable coupling means



Sept. 19, 1967 N. w. ELLMANN 3,342,179

BLOOD COLLECTION AND SAMPLING APPARATUS HAVING SEPARABLE COUPLING MEANSFiled June 18, 1965 A TTORNE) United States Patent ()fiice 3,342,179Patented Sept. 19, 1967 BLOOD COLLECTION AND SAMPLING APPA- RATUS HAVINGSEPARABLE COUPLING MEANS Norbert W. Ellmann, Chicago, Ill., assignor toAbbott Laboratories, North Chicago, 111., a corporation of IllinoisFiled June 18, 1965, Ser. No. 465,024 6 Claims. (Cl. 128-214.2)

This invention is directed to an apparatus for the collection andsampling of blood drawn from a donor. More specifically, the apparatusof the invention provides an in-line needle construction whereby aneedle mounted in a housing secured to the blood collection tubing canreadily be exposed for collection of a blood sample by the cammingaction of opposed faces of the housing which are defined by a rupturableline of weakness.

Co-pending patent application Ser. No. 267,752, filed Mar. 25, 1963, nowpatent No. 3,217,710, issued Nov. 16, 1965, shows a blood collectionapparatus provided with an in-line needle, the in-line needle beingmolded in a rupturable plastic hub member which is located in thecollection tubing. The hub member is separable to expose said needle,whereby the exposed needle can be inserted into a pilot tube for thecollection of a sample of the donors blood, for cross-matching purposes.In the fabrication of the in-line needle assembly as shown in saidco-pending application, the hub assembly is molded directly over thein-line needle per se. Consequently, when the hub portion is rupturedand the upper segment thereof is removed in order to expose the needle,it can often occur that the tight fit of the hub on the needle rendersit difiicult to remove the upper portion from the needle. This is, ofcourse, undesirable since it is essential to the economy of bloodcollection that the collection be susceptible of taking place in arelatively short period of time, because of the necessity of closeobservation by a trained technician.

The instant invention overcomes the aforementioned deficiencies of theprior art devices, by providing a line of weakness about the peripheryof the hollow body mem her in which the in-line needle is mounted. Theline of weakness is located at a skew angle relative to the longitudinalaxis of said body member, whereby a twisting force applied to the upperand lower section of said body member in opposed direction severs saidbody member at said score line. This provides opposed cam faces whichact upon each other to relatively separate the upper and lower bodysections to displace the upper body section from the needle, which isfixedly mounted in the lower body section, thereby facilitating removalof the upper body section and concomitant exposure of the inline needle.The ruptured score line also provides a tamper indication. Aself-lubricating plastic sleeve may be anchored in the upper bodysection releasably enveloping the in-line needle and extending beyondsaid line of weakness, to provide a leak-proof seal at the line ofweakness and to facilitate removal of said upper body section.

It is therefore an object of this invention to provide an in-line needleassembly construction which enables easy separation of the inline needlehousing to expose said in-line needle for collection of a blood sample.

Another object of this invention is to provide an in-line needleassembly having a housing including means adapted to facilitate relativedisplacement of adjacent sections of said body member to expose thepenetrating end of the in-line needle.

A further object of this invention is to provide an in-line needleassembly comprising a frangible plastic housing having a line ofweakness in skew relation to the longitudinal axis of the housing,whereby relative rotation in opposite directions of the housing sectionson either side of said line of weakness, severs said housing at saidline of weakness, the exposed edges at said severed line of weaknessproviding cam faces which act upon each other to longitudinally displacethe housing sections with respect to each other, thereby facilitatingremoval of the housing section covering the pointed end of said needle.

A concomitant object of this invention is to provide an in-line needleassembly comprising a needle housing having a scoredine in skew relationto the longitudinal axis thereof, and dividing said body member intoupper and lower sections, an in-line needle located in said housinghaving a lower end anchored in said lower section and a pointed endextending into said upper section, and a sleeve fixedly mounted in saidupper section, enveloping the in-line needle and extending beyond saidline of weakness into said lower section, whereby relative rotation ofsaid upper and lower sections with respect to each other breaks saidhousing at said score line and longitudinally separates said housingsections to facilitate removal of said upper section from said needlepoint section.

Other objects and advantages of the invention will be apparent as thesame become better understood by reference to the followingdetaileddescription when considered in connection with the attacheddrawings.

Referring to the drawings:

FIGURE 1 is a diagrammatic view showing the blood collection andsampling apparatus employing the in-line needle assembly of thisinvention;

FIGURE 2 is a cross-sectional view of the in-line needle assembly ofthis invention taken along line 2--2 of FIG- URE 1;

FIGURE 3 is a cross-sectional view taken along line 33 of FIGURE 2;

FIGURE 4 is a side elevational view, partly in section, showing thein-line needle assembly with the upper and lower sections of the housingrotated with respect to each other and with the opposed camming facesacting against each other;

FIGURE 5 is a side elevational view of the apparatus of FIGURE 1, afterthe device has been severed at its line of weakness and the housingsections separated; and

FIGURE 6 is a fragmentary side elevational view of a modified embodimentof the invention.

Referring now to FIGURE 1, there is shown a blood collecting andsampling apparatus generally indicated at 9 which includes a bloodcollecting container 10 in which blood from a donor is accumulated. Thecontainer 10 is provided with a lower end strap 11. through which asupporting member (not shown) can extend to support the container belowa donor whereby blood is collected in the container by gravity flow. Alower end portion 12 of the container 10 is provided with a centrallydisposed passage 13 to which a flexible tube 14 is connected forcommunication with the interior of the container 10. A ball closure 15in the passage 13 prevents tan anti-coagulant, normally contained in thecontainer 10, from escaping into tube 14. The ball 15 is displaced intothe container 10 prior to the collection of blood, so that blood canflow thereinto.

The container 10 is seen to be provided with fitments 17 and 13 for thelater administration of blood. The blood collecting container 10preferably takes the form of a bag composed of plasticizedpolyvinylchloride; however, the invention is not dependent upon anyparticular type of blood collecting container.

The in-line needle assembly 18 includes a housing generally indicated at20 having a passage 29 therethrough in which the in-line needle 40 isdisposed. The housing 20 includes an upper section 22 and a lowersection 21 severably interconnected by a neck portion having a frangiblescore line or line of weakness 24 formed therein. The flared end 41 ofin-line needle or cannula 40 is seen to be anchored in lower section 21(FIG. 2) and to have a pointed piercing end section extending beyondscore line 24 into upper section 22. Although the end 41 of the cannulais shown to be flared for purposes of keying, any suitable means, suchas projections or the like extending radially outwardly from the end ofthe cannula suitable for locking the cannula to lower section 21 ofhousing 20, can be utilized.

Intermediate neck section 23 of housing 20 is seen to be of considerablysmaller diameter than upper and lower body sections 21 and 22, tofacilitate severance of the housing at the score line when fingerpressure is applied in opposite directions to the pairs of integral wingmembers 27, 28 and 30, 31, which are formed on the respective lower andupper housing 21 and 22. Upper and lower sections 21 and 22 haverespective tapered end members 26 and 25 over which the end of tubinglength 14 and 14 are respectively secured, :as by friction-fit,heat-sealing or solvent sealing. The other end of tube 14 is connectedto an intravenous needle assembly 35 of conventional construction. Asterility-maintaining hood 3a is provided which removably fits overcannula 37. Tubes 14, 14', in-line needle assembly 18 and intravenousneedle assembly 35 comprise the collection conduit for the channeling ofblood from the venous system of a donor to the blood collectingcontainer Passage 29 has an enlarged eccentric cut-out or ledge formedat the upper end thereof in upper housing section 22. An accentricshoulder 52 of sleeve member 50 is mounted in cut-out 53, locking thesleeve 50 in the upper housing section (FIG. 3). Body section 51 ofsleeve 50 extends from the collar 52, beyond the score line 24 into thelower body section 21. The sleeve is mounted over the in-line needle 40,tightly and releasably enveloping the same.

It will be observed that score line 24 is located in skew relation tothe longitudinal axis of the passage 29, the score line beingsubstantially planar and extending around the entire periphery of theneck section 23 of housing 26 and terminating at its horizontalextremities in horizontal edge portions 33 and 34 (FIG. 2). Whenruptured, the score line presents opposed camming faces 55 and 56.

In the operation of the apparatus of this invention, the cannula 37 isinserted into the vein of a blood donor and blood is transfused throughthe collecting tubing 19 into the blood collection container, after theball has been removed from the end of tubing 14. When the container isfilled with blood, length of tubing 14' is temporarily closed as byclamping with a hemostat; tubing length 14 then is sealed off, byknotting, crimping with a metal ferrule, electronic sealing or the like.The in-line needle housing 20 is then grasped as by placing theforefinger and thumb of the left hand on wings and 31 and the thumb andforefinger of the right hand on wings 27 and 28. Finger pressure is thenapplied to the wing members, to rotate the upper and lower body sectionsin opposing directions, as shown in FIGURE 4. Initial rotation of therespective upper and lower housing sections as described, severs thesesections along the score line 24 and, as rotation is continued, theopposed cam surfaces 55 and 56, which are opposingly inclined, interactin camming relationship to each other to drive the upper and lowerhousing sections 21 and 22 apart along the longitudinal axis of passage29. When the respective body sections have been rotated 180, therelative displacement of the housing sections by virtue of the cammingaction is completed, and these sections are then grasped in the hands ofthe technician and pulled apart to expose point 42 of in-line needle 40.The point of the in-line needle 40 is then inserted in the rubberstopper of an evacuated pilot tube (not shown), the hemostat which hasclamped tubing 14' is removed, and blood from cannula 37 flows throughtube 14' and in-line needle 40 into the pilot tube. This provides asterile blood sample. The pilot tube is properly marked with the sameidentifying markings as container 10, for subsequent cross-matchingpurposes at the time that it is desired to administer the blood incontainer 10 into a patient.

In constructing in-line needle assembly 18, housing 20 is molded overneedle 40. Consequently, because of the tight fit which is obtainedduring molding, the camming action effected by the opposing forces ofcam faces 55 and 56 forces the housing sections 21 and 22 apart andloosens the cannula in upper section 22 for removal therefrom.

To further facilitate the removal of the in-line needle 49, sleeve 50 isinserted over the cannula, in tight-fitting relation, prior to themolding of the housing 20 thereover. This facilitates the removal of theupper housing section, since the sleeve St) is fabricated of aself-lubricating material having a low coefiicient of friction, such asnylon. The in-1ine needle 40 is therefore easily slidable out of sleeve50. The sleeve 50 also serves to maintain the sterility of the in-lineneedle 40 and to prevent leakage of blood by providing a tight seal atthe score line to prevent passage of blood or contaminants through thescore line perforations.

The eccentric shoulder 52 of sleeve 50 serves to anchor the shoulder andconsequently the upper end of the sleeve in upper housing section 22, sothat the sleeve is displaced with upper housing section 22 when theupper and lower housing sections are severed by twisting. Additionally,this anchoring of the sleeve enables the sleeve to be removed from thein-line needle when the upper and lower body sections are pulled apart,as best shown in FIG. 5.

It will be appreciated that, although the line of weakness is shown inthe drawings as being located at an angle of approximately 45 withrespect to the longitudinal axis of passage 29, this angle can be variedwithout departing from this invention. For example, by increasing theangle of the score line with respect to the longitudinal axis of passage29, the longitudinal displacement of the housing sections obtained bythe interaction of cam faces 55 and 56 can be increased. By decreasingthe angle of the score line the mechanical advantage obtained by theinteracting cam faces can be increased.

Furthermore, although the score line 24 is shown in the preferredembodiment as being of a substantially planar configuration havinghorizontal edge portions 33 and 34, it is within the scope of thisinvention for the score line to have a completely planar configurationor to have a continuously curved shape such as shown by score line 24'of FIG. 7. So long as the score line is a substantially continuous curveor substantially straight line, convenient camming action of the camfaces is obtained. It will further be appreciated that although the neck23 is shown in the drawing as being of circular cross-section, thecross-sectional shape of such neck and its dimensions may be variedwithout departing from the spirit and scope of this invention.

The housing 20 is preferably a unitary, molded member of rigid,frangible plastic material such as a polycarbonate (commerciallyavailable as Lexan) or an acetate butyrate styrene copolymer(commercially available as Crythat other forms of lines of weakness canbe utilized, such as by necking down the plastic in the area which isdesired to be broken.

The above-described embodiment of the invention is illustrative incharacter only, and it will be understood that modifications in form anddetail in the invention can be made without departing from the spiritand scope of the invention. Accordingly, the present invention is not tobe considered as limited except as is consonant with the scope of thefollowing claims.

I claim:

1. Blood collection apparatus comprising: a blood collection container,a hypodermic needle, a hollow frangible housing having an upper end anda lower end, a first length of flexible tubing intercomrnunicating saidcontainer and said upper end, a second length of tubingintercomrnunicating said lower end and said hypodermic needle, a line ofweakness defined by said housing about the periphery thereof in skewrelation to the longitudinal axis of said housing providing opposed camfaces and conditioning said housing for separation into an upper sectionand a lower section, a cannula mounted in said housing and having afirst end fixedly mounted in said lower section and a pointed endremovably extending into said upper section, whereby said cam facesinteract to longitudinally separate said upper and lower sections whensaid sections are twisted in opposite directions relative to each other.

2. Blood collection apparatus comprising: a blood collection container,a hypodermic needle, a hollow plastic housing having an upper end and alower end, a first length of flexible tubing intercomrnunicating saidcontainer and said upper end, a second length of tubingintercomrnunicating said lower end and said hypodermic needle, asubstantially planar line of weakness defined by said housing about theperiphery thereof in skew relation to the longitudinal axis of saidhousing and conditioning said housing for separation into an uppersection and a lower section, a cannula mounted in said housing andhaving a first end fixedly mounted in said lower section and a pointedend removably extending into said upper section, whereby the edges ofsaid line of weakness act as camming surfaces to facilitate separationof said upper and lower sections when said sections are twisted inopposite directions relative to each other.

3. Blood collection apparatus comprising: a blood collection container,a hypodermic needle, a hollow plastic housing having an upper end and alower end, a first length of flexible tubing intercomrnunicating saidcontainer and said upper end, a second length of tubingintercommunicating said lower end and said hypodermic needle, asubstantially planar score line defined by said housing about theperiphery thereof in skew relation to the longitudinal axis of saidhousing and conditioning said housing for separation into an uppersection and a lower section, a cannula mounted in said housing andhaving a first end fixedly mounted in said lower section and a pointedend removably extending into said upper section, a pair of opposed wingmembers mounted on each of said upper and lower sections, whereby theedges of said housing act as camming surfaces to longitudinally separatesaid upper and lower sections when said sections are twisted in oppositedirections relative to each other by application of finger pressure tosaid wing members.

4. Blood collection apparatus comprising: a blood collection container,a hypodermic needle, a plastic housing defining a longitudinallyextending passage and having an upper end and a lower end, a firstlength of flexible tubing intercomrnunicating said container and saidupper end, a second length of tubing intercomrnunicating said lower endand said hypodermic needle, a peripherally extending line of weaknessdefined by said housing in skew relation to said passage andconditioning said housing for separation into an upper section and alower section, a cannula in said passage having a first end fixedlymounted in said lower section and a point removably extending into saidupper section, a pair of opposed wing members mounted in opposition oneach of said upper and lower sections, whereby application of twistingfinger pressure to said wing members to rotate said sections withrespect to each other severs said housing at said score line and thesevered score line faces act as camming surfaces to separate said bodysections, thereby facilitating removal of said upper section to exposesaid cannula point for insertion into a pilot tube.

5. Blood collection apparatus comprising: a blood collection container,a hypodermic needle, a plastic housing defining a longitudinallyextending passage and having an upper end and a lower end, a firstlength of flexible tubing intercomrnunicating said container and saidupper end, a second length of tubing intercomrnunicating said lower endand said hypodermic needle, a peripherally extending substantiallyplanar score line defined by said housing in skew relation to saidpassage and conditioning said housing for separation into an uppersection and a lower section, a cannula in said passage having a firstend fixedly mounted in said lower section and a point removablyextending into said upper section, a sleeve surrounding a portion ofsaid cannula and having one end fixedly secured to said upper sectionand a second end removably mounted in said lower section, a pair ofopposed wing members mounted in opposition on each of said upper andlower sections, whereby application of twisting finger pressure to saidwing members to rotate said sections with respect to each other severssaid housing at said score line and the severed score line faces act ascamming surfaces to separate said sections, thereby facilitating removalof said upper section to expose said cannula point for insertion into apilot tube.

6. Blood collection apparatus comprising: a blood collection container,a hypodermic needle, a frangible plastic housing defining alongitudinally extending passage and having an upper end and a lowerend, a first length of flexible tubing intercomrnunicating saidcontainer and said upper end, a second length of tubingintercommunicating said lower end and said hypodermic needle, aperipherally extending substantially planar score line defined by saidhousing in skew relation to said passage and conditioning said housingfor separation into an upper r section and a lower section, a cannula insaid passage having a flared end fixedly molded in said lower sectionand a pointed end removably extending into said upper section, aflexible sleeve mounted in said passage releasably encircling saidcannula and having a first end anchored in said upper section and aremovable second end extending beyond said score line into said lowersection, a pair of opposed wing members mounted in opposition on each ofsaid upper and lower sections, whereby application of twisting fingerpressure to said wing members to rotate said sections with respect toeach other severs said housing at said score line and the severed scoreline faces act as camming surfaces to separate said sections therebyfacilitating removal of said upper section and said flexible sleeve toexpose said cannula point for insertion into a pilot tube.

References Cited UNITED STATES PATENTS 3,073,307 1/1963 Stevens 128-2213,127,892 4/ 1964 Bellamy et al 128-2142 3,217,710 11/1965 Beall et a1.128-214.2

FOREIGN PATENTS 10,085 1898 Great Britain. 875,361 8/ 1961 GreatBritain.

RICHARD A. GAUDET, Primary Examiner.

DALTON R. TRULUCK, Examiner.

1. BLOOD COLLECTION APPARATUS COMPRISING: A BLOOD COLLECTION CONTAINER,A HYPODERMIC NEEDLE, A HOLLOW FRANGIBLE HOUSING HAVING AN UPPER END ANDA LOWER END, A FIRST LENGTH OF FLEXIBLE TUBING INTERCOMMUNICATING SAIDCONTAINER AND SAID UPPER END, A SECOND LENGTH OF TUBINGINTERCOMMUNICATING SAID LOWER END AND SAID HYPODERMIC NEEDLE, A LINE OFWEAKNESS DEFINED BY SAID HOUSING ABOUT THE PERIPHERY THEREOF IN SKEWRELATION TO THE LONGITUDINAL AXIS OF SAID HOUSING PROVIDING OPPOSED CAMFACES AND CONDITIONING SAID HOUSING FOR SEPARTION INTO AN UPPER SECTIONAND A LOWER SECTION, A CANNULA MOUNTED IN SAID